Expert eyes on your data
Site training, motivation and meticulous clinical monitoring in accordance with ICH-GCP standards are crucial to obtaining evaluable study data. SCOPE builds its local monitoring teams with experienced clinical research associates (CRAs), closely managing site performance to avoid protocol violations, maintaining low query rates and ensuring study enrolment as well as on-site logistics.
Scope International deploys teams of local office-based, permanent CRAs from national offices providing a cost effective solution. Consistently high quality clinical monitoring is ensured through periodic co-monitoring of all trials, coupled with project-specific monitoring plans and periodic CRA training and mentorship delivered by CRA managers.
All our CRAs have considerable clinical research expertise, broad therapeutic experience and strong communication skills that are vital for good site-sponsor relationships.
At Scope International, we believe that clinical operations is not only about making sure that the project runs smoothly through high quality monitoring and management, but also about delivering personalised service. Selected for their strong interpersonal skills, our CRAs build close site and sponsor relationships.
Our site management process ensures fast, proactive support that you and sites can rely on. Our CRAs provide general and study-specific site training (e.g. ICH-GCP, protocol, EDC systems), have continuous site overview, perform remote monitoring and support the sites to optimize the recruitment strategy. They maintain close personal contacts to identify and solve any potential problems and to maintain site motivation.
- Expert, experienced CRAs (permanent, local and office-based)
- All monitoring activities in accordance with ICH-GCP standards
- Co-monitoring and training programs to ensure quality across all sites and countries
- Risk-based monitoring
- Remote monitoring
- Site overview and proactive site management
- Site training and support with study documentation
- Patient recruitment strategies